Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0141-2025 — GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844-002-01058424; 4) 2082844-002-01069017; 5) 2082844-002-01089666; 6) 2082844-002-01090474; 7) 2082844-002-01091269; 8) 2082844-002-01093489;

U.S. FDA — Device Enforcement · United States · 2023-06-06 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0141-2025
Date of alert: 2023-06-06
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: DATEX--OHMEDA, INC.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 01040417

Reported risk: Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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